Growth Hormone DeficiencyPhase 3NCT02410356
Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
A Phase 3 study testing TV-1106 and dGH in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc. at 50 sites in 8 countries.
Trial summary
This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- TV-1106 and dGH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 30 Apr 2015to 30 Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females 18 years of age or over
- diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
- treated with a stable dose of daily rhGH for at least 3 months prior to screening
- stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening
- Other criteria apply, please contact the investigator for more information
Who cannot join
- patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
- Presence of contraindications to rhGH treatment
- patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
- patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year
- patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
- presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.
Show all 9Show fewer
- patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%
- patients using weight reducing agents or appetite suppressants
- Other criteria apply, please contact the investigator for more information
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
United States32 sites
Teva Investigational Site 13144
Arlington, Texas, 76014
Teva Investigational Site 13137
Artesia, California, 90701
Teva Investigational Site 13128
Asheville, North Carolina, 28803
Teva Investigational Site 13143
Brooklyn, New York, 11235
Teva Investigational Site 13163
Dallas, Texas, 75218
Teva Investigational Site 13155
Denver, Colorado, 80209
Teva Investigational Site 13135
Detroit, Michigan, 48202
Teva Investigational Site 13504
Federal Way, Washington, 98003
Teva Investigational Site 13162
Fort Lauderdale, Florida, 33312
Teva Investigational Site 13166
Fountain Valley, California, 33155-6541
Teva Investigational Site 13146
Henderson, Nevada, 89052
Teva Investigational Site 13136
Homestead, Florida, 33030
Teva Investigational Site 13130
Houston, Texas, 77079
Teva Investigational Site 13141
Houston, Texas, 77084
Teva Investigational Site 13154
Houston, Texas, 77090
Teva Investigational Site 13165
Lakewood, California, 90712
Teva Investigational Site 13147
Las Vegas, Nevada, 89148
Teva Investigational Site 13138
Miami, Florida, 33126
Teva Investigational Site 13152
Miami, Florida, 33130
Teva Investigational Site 13161
Miami, Florida, 33145
Teva Investigational Site 13500
Miami, Florida, 33155-6541
Teva Investigational Site 13503
Miami, Florida, 33175
Teva Investigational Site 13148
Miami Lakes, Florida, 33016
Teva Investigational Site 13502
New York, New York, 10016
Teva Investigational Site 13140
New York, New York, 10032
Teva Investigational Site 13158
Newark, Delaware, 19713
Teva Investigational Site 13159
Norfolk, Virginia, 23507
Teva Investigational Site 13134
Pembroke Pines, Florida, 33024
Teva Investigational Site 13142
Pittsburgh, Pennsylvania, 15212
Teva Investigational Site 13164
Seattle, Washington, 98122
Teva Investigational Site 13157
Tacoma, Washington, 98405
Teva Investigational Site 13129
West Palm Beach, Florida, 33401
Hungary6 sites
Teva Investigational Site 51202
Budapest, 1062
Teva Investigational Site 51206
Budapest, 1088
Teva Investigational Site 51205
Debrecen, 4032
Teva Investigational Site 51204
Pécs, 7624
Teva Investigational Site 51208
Szeged, 6725
Teva Investigational Site 51207
Szolnok, 5000
Czechia3 sites
Teva Investigational Site 54118
Brno, 656 91
Teva Investigational Site 54119
Moravskoslezsky, 708 00
Teva Investigational Site 54116
Plzensky, 304 60
Greece3 sites
Teva Investigational Site 63059
Athens, 11527
Teva Investigational Site 63058
Chaïdári, 12462
Teva Investigational Site 63060
Ioannina
Spain3 sites
Teva Investigational Site 31129
Badalona, 08916
Teva Investigational Site 31121
Córdoba, 14004
Teva Investigational Site 31125
Madrid, 28805
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency
This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.
- Conditions
- Growth Hormone Deficiency
- Being tested
- TV-1106, dGH
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-1106Drug
Also called rhGH
The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.
dGHDrug
Also called rhGH, Somatropin
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
| Study group | Role | What they receive |
|---|---|---|
| TV-1106 | Experimental | TV-1106 to be injected once weekly. Receives: Drug: TV-1106 |
| dGH | Active comparator | dGH to be given as daily injections. Receives: Drug: dGH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events
Safety of TV-1106 compared to reference drug
Measured: 48 weeks
Secondary outcomes (1)
Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score
Measured: Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start30 Apr 2015
- Primary completion29 Feb 2016
- Study completion30 Apr 2016
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410356
- Sponsor's protocol ID
- TV1106-IMM-30022
- Status last verified
- Dec 2021
- First submitted
- 30 Mar 2015
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency
- ClinicalTrials.gov ID
- NCT02410356
- Acronym / sponsor ID
- TV1106-IMM-30022
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TV-1106 | Experimental | Drug: TV-1106TV-1106 to be injected once weekly. |
| dGH | Active comparator | Drug: dGHdGH to be given as daily injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- males and females 18 years of age or over
- diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
- treated with a stable dose of daily rhGH for at least 3 months prior to screening
- stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening
Key exclusion criteria (9 listed)
- patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
- Presence of contraindications to rhGH treatment
- patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
- patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year
- patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TV-1106Also: rhGHThe volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range. | Drug | TV-1106 |
| dGHAlso: rhGH, SomatropinThe dose levels of dGH will be the same as the stable rhGH dose taken prior to the study. | Drug | dGH |
Primary outcome
Percentage of participants with adverse events
Time frame: 48 weeks
Safety of TV-1106 compared to reference drug
1 secondary outcome
Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score
Time frame: Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
50 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TV-1106 and dGH in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc. at 50 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Hungary, Czechia, Greece, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with adverse events (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.